Cleared Traditional

K151185 - AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC)

K151185 · Abl Medical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
277d
Days
-
Risk

K151185 is an FDA 510(k) clearance for the AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wou.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Abl Medical, LLC (American Fork, US). The FDA issued a Cleared decision on February 5, 2016 after a review of 277 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K151185

510(k) Number K151185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2015
Decision Date February 05, 2016
Days to Decision 277 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 115d · This submission: 277d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Biologics Consulting Group, Inc.
Calley Herzog

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRO Dressing, Wound, Drug

All 638
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K151185.
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Nexodyn AOS Wound Care Solution
K151168 · Apr Applied Pharma Research SA · Dec 2015